Deucrictibant granted orphan drug status in EU for angioedemas

Deucrictibant, an oral therapy being developed for bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema, has been granted orphan drug status in the European Union. This designation, granted by the European Commission, intends to back the development of therapies to diagnose, prevent, or treat rare…

Phase 3 trial to test extended deucrictibant as treatment for HAE

Pharvaris said it plans to initiate a Phase 3 clinical trial by the end of the year to test an oral, extended-release tablet formulation of deucrictibant as a preventive, or prophylactic, treatment for hereditary angioedema (HAE). Called CHAPTER-3, the trial will assess the treatment’s safety and efficacy…

Data show sustained benefits of deucrictibant for HAE attacks

Treatment with deucrictibant continued to successfully prevent and treat swelling attacks in people with hereditary angioedema (HAE), according to new data from the open-label extension portions of two clinical trials. The findings, presented at the Bradykinin Symposium held in Berlin Sept. 5-6, support the use of deucrictibant…

Preparations underway for Phase 3 trial of deucrictibant

Regulatory authorities in Japan, the U.S., and the European Union have aligned on plans for a Phase 3 clinical trial to test the oral medication deucrictibant as a prophylactic (preventive) treatment to reduce the risk of swelling attacks in people with hereditary angioedema (HAE). With alignment from the U.S.

Deucrictibant shows promise for treating acquired angioedema

Deucrictibant, an experimental treatment for hereditary angioedema (HAE), now has shown promising efficacy as an on-demand and prophylactic, or preventive, treatment in three patients with acquired angioedema. The findings, from a small clinical trial, suggest that “deucrictibant has the potential to effectively and safely treat and prevent…

FDA lifts hold on deucrictibant as preventive treatment for HAE

The U.S. Food and Drug Administration (FDA) has lifted its clinical hold on deucrictibant as a prophylactic, or preventive, treatment for hereditary angioedema (HAE) attacks. Deucrictibant developer Pharvaris said it will resume clinical testing of the therapy in HAE, including restarting the open-label extension part of the…

Deucrictibant reduces rate of HAE swelling attacks in Phase 2 trial

Prophylactic, or preventive, treatment with deucrictibant significantly reduced the rate of swelling attacks among adults with hereditary angioedema (HAE) in a Phase 2 clinical trial. “These study results, together with the compelling data from our on-demand program, further strengthens our confidence that deucrictibant can become the preferred option…

Pharvaris gearing up to launch Phase 3 trial of PHVS416 in 2024

Pharvaris is now gearing up startup activities with clinical site investigators and staff to launch a Phase 3 trial next year of PHVS416 — an immediate-release capsule formulation of deucrictibant — as an on-demand treatment for hereditary angioedema (HAE). The Switzerland-based clinical-stage company recently met with the U.S. Food…